BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFREEZE CRYOSPRAY ABLATION SYSTEM

    MDR report key: 3187199 · Received June 20, 2013

    Report

    Report Number
    3004534508-2013-00001
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 19, 2013
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    PMA / PMN Number
    K113021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL CRYOTHERAPY WAS GIVEN (B)(6) 2013. PATIENT RETURNED FOR REPEAT CRYOTHERAPY ON (B)(6) 2013 AND STATED HE WAS HAVING MILD DYSPHAGIA. STRICTURE WAS NOTED AT 38.5, WHICH WAS THE AREA OF INITIAL CRYOTHERAPY. PATIENT HAD ALSO HAD EMR AND BARRX YEARS AGO FOR DYSPLASTIC BARRETTS. PATIENT WAS DILATED UP TO 48FR. PATIENT RETURNED (B)(6) 2013. PATIENT WAS RE-DILATED AND WILL RETURN FOR ANOTHER DILATION IN 4 DAYS. EVENT WAS FIRST REPORTED (B)(6) 2013, TO THE (B)(4) QUALITY ASSURANCE REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281505 TRUFREEZE CRYOSPRAY ABLATION SYSTEM CRYOSPRAY GEH CSA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention