BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 1773598 · Received July 20, 2010

    Report

    Report Number
    3004534508-2010-00013
    Event Type
    Injury
    Date Received
    July 20, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 21, 2010
    Manufacturer
    CSA MEDICAL INC
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH CARE PROFESSIONAL (NP) INDICATED DEVICE OPERATED NORMALLY. NO ERRORS OF BUILT-IN TEST PERFORMED AT SYSTEM START-UP WERE NOTED. VERIFICATION TESTING OF THE DEVICE BY CSA MEDICAL ALSO CONFIRMED THE DEVICE WAS PERFORMING NORMALLY. PT HAD BEEN TREATED WITH CRYOSPRAY TWICE ((B)(6) 2010, AND (B)(6) 2010) PRIOR TO THE TREATMENT ON (B)(6) 2010, WITH NO COMPLICATIONS. PT HAS BEEN ON PLAVIX/ASPIRIN REGIMEN FOR CARDIAC ISSUES AND THE PHYSICIAN CHOSE CRYOTHERAPY SPECIFICALLY DUE TO LACK OF BLEEDING AFTER TREATMENT.

    Description of Event or Problem · 1

    PT PRESENTED TO SCHEDULED ESOPHAGOGASTRODUODENOSCOPY (EGD) FOR CRYOSPRAY TREATMENT OF BARRETT'S ESOPHAGUS WITH HIGH GRADE DYSPLASIA (HGD) ON (B)(6) 2010. PT UNDERWENT TREATMENT WITHOUT COMPLICATIONS AND RETURNED HOME. APPROXIMATELY TWO WEEKS POST TREATMENT, PT HAD SEVERE SHORTNESS OF BREATH AND DIZZINESS (PT DESCRIBED SEVERITY AS BEING UNABLE TO WALK). HE WAS TAKEN TO HIS LOCAL EMERGENCY ROOM WHERE HGB WAS RUN. TWO (2) UNITS OF BLOOD WERE TRANSFUSED. PT ALSO UNDERWENT EGD AND WAS DETERMINED TO HAVE AN ESOPHAGEAL ULCER/ERYTHEMA. PT DID NOT HAVE ULCERATION OR MUCOSAL BREAK IN THE ESOPHAGUS PRIOR TO TREATMENT. PHYSICIAN AT LOCAL EMERGENCY ROOM SUGGESTED THAT THE AREA OF ULCERATIONS WAS THE SAME AS AREA OF CRYOSPRAY TREATMENT BUT HAS NOT BEEN CONFIRMED FIRSTHAND BY TREATING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOSPRAY ABLATION SYSTEM CRYOSPRAY GEH CSA MEDICAL INC CC2-NAM

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R PT WAS ON A REGIMEN OF PLAVIX AND| ASPIRIN