BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYO SPRAY ABLATION

    MDR report key: 2253981 · Received September 16, 2011

    Report

    Report Number
    3004534508-2011-00005
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    June 8, 2011
    Report Date
    August 19, 2011
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN FOLLOWED INSTRUCTIONS FOR USE AND TREATED WITHIN THE CLEARED INDICATIONS OF THE DEVICE. SYSTEM OPERATED NORMALLY AND PASSED SUBSEQUENT FIELD VERIFICATION TESTS. PHYSICIAN BELIEVES THE PERFORATION WAS RELATED TO EXPANDING GAS FROM THE CRYO SPRAY PROCEDURE. THE IFU CAUTIONS TREATING PATIENTS WITH COMPROMISED TISSUE THAT MAY NOT BE ABLE TOLERATE TREATMENT. THE PATIENT'S PREVIOUSLY INSERTED PEG TUBE MAY HAVE WEAKENED TISSUE THAT RESULTED IN A PERFORATION WHEN COMBINED WITH THE PRESSURE FROM THE EXPANDING GAS.

    Description of Event or Problem · 1

    PT PRESENTED TO OUTPATIENT ESOPHAGOGASTRODUODENOSCOPY (EGD) FOR PALLIATIVE CRYO SPRAY TREATMENT OF ESOPHAGEAL NEOPLASIA ON (B)(6) 2011. TWO CYCLES OF 20 SECOND CRYO SPRAY WERE RENDERED AT 3-4 TREATMENT SITES. A DECOMPRESSION TUBE WAS USED WITH ACTIVE SUCTION AND THE ABDOMEN WAS MONITORED FOR DISTENTION PER THE INSTRUCTIONS FOR USE (IFU) WITHOUT COMPLICATION. POST TREATMENT, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. PATIENT WAS MONITORED FOR 23 HOURS BEFORE BEING ADMITTED TO THE HOSPITAL. THE PERFORATION WAS REPAIRED SURGICALLY AND A NEW PEG FEEDING TUBE WAS PUT IN PLACE. THE PATIENT WAS RELEASED 4-5 DAYS LATER. PATIENT HAS RESPONDED WELL TO CRYOTHERAPY AND HAS IMPROVED EXPERIENCE EATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYO SPRAY ABLATION CRYO SPRAY ABLATION GEH CSA MEDICAL CC2-NAM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R