FDA Medical Device Recalls (openFDA)
PENTAX of America Inc: Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
- Recall number
- Z-1325-2019
- Recalling firm
- PENTAX of America Inc
- Product
- Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
- Status
- Terminated
- Initiated
- 2018-12-03
- Posted
- not on file
- Terminated
- 2020-08-14
- Reason
- Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
- Root cause
- Under Investigation by firm
- Action
- Letters dated 12/3/2018 were issued via USPS mailing on 12/3/2018 explaining the issue and instructing the customer to discontinue use of the device and to ensure all potential users in the customer facility are aware of the recall notification and recommended actions. For questions regarding this action, please contact PENTAX Medical Customer Service. Tel: 650-318-5899 (8:30 AM 5:00 PM, Monday Friday, PST) Fax: 650-318-5899 Email: RMA@C2Therapeutics.com
- Quantity
- 157 devices
- Distribution
- Distribution was made to CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada, Germany, and the Netherlands.
- Lot, serial or model codes
- Lot/Serial numbers: 06152018-02, 06252018-03, 07062018-01, 07232018-02, 08102018-01, 08172018-06, 08292018-04, and 9172018-01.
- 510(k) numbers
- ["K163684"]
- PMA numbers
- not on file
- Product code
- GEH
- Firm FEI
- 3008780134
- Firm city
- Redwood City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28