{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Redwood City",
      "address_1": "303 Convention Way",
      "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.",
      "address_2": "Ste 1",
      "product_quantity": "45",
      "code_info": "All lot numbers",
      "center_classification_date": "20190301",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) to states of:: CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA;; and countries: Canada, Germany, and Netherlands.",
      "state": "CA",
      "product_description": "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.",
      "report_date": "20190313",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "PENTAX of America Inc",
      "recall_number": "Z-0970-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81695",
      "termination_date": "20200821",
      "recall_initiation_date": "20181203",
      "postal_code": "94063-1465",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}