C2 CryoBalloon Controller — Class II medical device recall Z-0970-2019
Terminated recall by PENTAX of America Inc, reported 2019-03-13, distributed nationwide. The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitro
| Recall number | Z-0970-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PENTAX of America Inc, Redwood City, CA, United States |
| Recall initiated | 2018-12-03 |
| Classified | 2019-03-01 |
| Reported by FDA | 2019-03-13 |
| Terminated | 2020-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, NL |
| Quantity | 45 |
| Model numbers | FG-1017 |
Product
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 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.
Reason for recall
The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0970-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.